Study of Linperlisib with Camrelizumab and Pegaspargase for Treating Advanced or RelapsedRefractory NKT-cell Lymphoma Phase IbII Clinical Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are studying patients with relapsed, refractory, or advanced Natural KillerT-Cell Lymphoma NKTCL to explore a new combination treatment involving Linperlisib, Camrelizumab, and Pegaspargase. This prospective, single-arm clinical trial includes an initial safety phase phase Ib to determine the recommended dose and evaluate side effects, followed by phase II to assess the safety and effectiveness of this combined treatment in these patients. The treatment involves oral Linperlisib taken daily 80 mg in phase Ib recommended phase II dose thereafter, intravenous Camrelizumab given every three weeks, and intramuscular Pegaspargase also given every three weeks. Each treatment cycle lasts 21 days. Dexamethasone is given on days 1 to 4 but not on the same day as Camrelizumab. The study includes close safety monitoring, especially for allergic reactions and infusion responses. Participants will be followed through at least six treatment cycles, with evaluations of tumor response at multiple points, including after the 2nd, 4th, and 6th cycles. Researchers will assess outcomes such as the best objective response rate, progression-free survival, overall survival, and disease control rate, with follow-up lasting up to two years. Safety monitoring will also include lab tests, imaging, and observation for adverse events throughout the study.

Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma